NATIONAL HIGHWAY SECTOR SCHEMES FOR QUALITY MANAGEMENT IN HIGHWAY WORKS SCHEME 3. Particular requirements for the application of ISO 9001:2015 FOR

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1 NATIONAL HIGHWAY SECTOR SCHEMES FOR QUALITY MANAGEMENT IN HIGHWAY WORKS SCHEME 3 Particular requirements for the application of ISO 9001:2015 FOR STOCKING AND DISTRIBUTION ACTIVITIES FOR MECHANICAL FASTENERS (Applies to Manufacturers, Importers and Distributors of Mechanical Fasteners) Published by the Sector Scheme Advisory Committee for Mechanical Fasteners (SSACMF) Endorsed for publication by the Chairman of the SSACCP Name: R Reed Date: 31 July 2016 Issue 1 [9001:2015] Page 1 of 48 NHSS 3: 31 July 2016

2 DOCUMENT CONTROL Issue Statement Issue 1 [9001:2015] 31 July 2016 Revisions It is the SSACMF s policy that the issue of any revision to this document shall be an issue of the full document rather than individual pages. The following gives details of the changes that have been made in this and previous editions of the document. Issue Issue 1 [9001:2015] Amendments First Issue This Sector Scheme is one of the series of NHSSs, which are bespoke integrated management schemes within an ISO 9001:2015 framework that have been developed to define particular requirements within ISO 9001:2015 as it applies to a particular activity/industry within the United Kingdom. Note: This document has been produced to supersede the Issue 6 [9001:2008] version (which relates to ISO 9001:2008), however the Issue 6 [9001:2008] version (or a later updated version) will continue to have validity until September 2018 when the 2008 version of ISO 9001 will become obsolete. Issue history for revisions of the SSD to versions of ISO 9001 prior to ISO 9001: 2015 UKAS Issue 1 28 February 2010 UKAS Issue 2 March 2011 UKAS Issue 3 February 2012 UKAS Issue 4 February 2013 UKAS Issue 5 January 2015 Issue 6 [9001:2008] July 2016 Issue 1 [9001:2015] Page 2 of 48 NHSS 3: 31 July 2016

3 CONTENTS Page No COVER SHEET 1 DOCUMENT CONTROL 2 CONTENTS 3 COMPOSITION OF SECTOR SCHEME ADVISORY COMMITTEE 5 EXCLUSION OF LIABILITY 5 COPYRIGHT 5 SELECTION OF CERTIFICATION BODY 5 IMPLEMENTATION 6 INTRODUCTION 6 PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001: SCOPE 9 2. NORMATIVE REFERENCE 9 3. TERMS, DEFINITIONS AND ABBREVIATIONS QUALITY MANAGEMENT SYSTEM REQUIREMENTS 13 APPENDIX A: NOT USED 23 APPENDIX B: REFERENCE AND ASSOCIATED DOCUMENTS (BIBLIOGRAPHY) 24 APPENDIX C: NOT USED 25 APPENDIX D: NOT USED 26 APPENDIX E: APPENDIX F: APPENDIX G: APPENDIX G1 GUIDANCE FOR THE CONTROL OF MONITORING AND MEASURING EQUIPMENT CERTIFICATION BODIES ACCREDITED FOR THIS SECTOR SCHEME THE ROLE OF CERTIFICATION BODIES AND AUDITOR QUALIFICATIONS GUIDANCE TO CERTIFICATION BODY ASSESSORS AND OTHER AUDITORS Issue 1 [9001:2015] Page 3 of 48 NHSS 3: 31 July 2016

4 APPENDIX H: ORGANIZATION ACCEPTANCE AND GUIDELINES FOR NEW ENTRANTS 38 APPENDIX J1: FEEDBACK TO COMMITTEE CHAIRPERSON 39 APPENDIX J2: APPENDIX J3: APPENDIX K: FEEDBACK TO CERTIFICATION BODIES &/OR NOTIFIED BODIES FEEDBACK TO CLIENT BODIES ON POLICING OF NATIONAL HIGHWAY SECTOR SCHEME REGISTRATION THE INTERPRETATION OF CERTIFICATES ISSUED BY CERTIFICATION BODIES APPENDIX L: GUIDANCE FOR CLIENTS 43 APPENDIX M: NOT USED 44 APPENDIX N: GUIDANCE FOR OTHER NHSS COMMITTEES AND ORGANIZATIONS REGISTERED TO ANOTHER NHSS, FOR ACTIVITIES THAT INCLUDE STOCKING AND DISTRIBUTION ACTIVITIES FOR MECHANICAL FASTENERS 45 APPENDIX O: HOW TO REGISTER ON THE SCHEDULE OF SUPPLIERS 46 APPENDIX P: INSPECTION AND TESTING REQUIREMENTS FOR MECHANICAL CHARACTERISTICS 47 Issue 1 [9001:2015] Page 4 of 48 NHSS 3: 31 July 2016

5 COMPOSITION OF SECTOR SCHEME ADVISORY COMMITTEE FULL MEMBERS The Advisory Committee is incorporated into the BCSA s Working Group for Fasteners, as follows: Certification Bodies Certification Body Group represented by Steel Construction Certification Scheme (SCCS) (Lead Certification Body) and Lloyds Register Quality Assurance (LRQA) Clients - Highways England Industry BCSA (Representatives from BCSA Working Group for Fasteners representing the steelwork industry, steelwork fabricators, stockist distributors of mechanical fasteners, manufacturers of mechanical fasteners) EXCLUSION OF LIABILITY The Sector Scheme Advisory Committee for Mechanical Fasteners (SSACMF) 1 have and accept no liability whatsoever for any failure of any system or systems assessed under this Sector Scheme Document or for the quality, fitness for purpose, or safety of any product or service which is the subject of such assessment, 2 do not provide any representation or warranty as to any aspect of any such system, product or service, and 3 hereby expressly exclude all and any liability or responsibility (however alleged to arise) for or in connection with the provision of any service or product or any use of any product, all and any such liability or responsibility attaching exclusively to the producer (or user as the case may be) thereof. COPYRIGHT Permission is granted to reproduce and distribute this document subject to the restriction that the complete document must be copied without alteration, addition or deletion. This is subject to material not being used in a derogative manner or in misleading context. The source of the material must be acknowledge as SSACMF copyright and the title of the document must be included when being reproduced as part of another publication or service. SELECTION OF CERTIFICATION BODY It is important to note that due to the specific requirements for assessor competence required by this Sector Scheme a technical expert may be appointed by the SSACMF to assist UKAS in the assessment of Certification Bodies (CB) as described in Appendix G (clause 3.1). Prospective companies seeking registration under this scheme should ensure that they engage a Certification Body specifically accredited to assess against the requirements of this SSD. Specifiers, consultants, engineers etc. that require confirmation of compliance with the Contract Specification in respect of a Supplier s registration to this Sector Scheme or the supply of products/materials should confirm the current status of the quality management system certificate issuer and that specific reference is made to this Sector Scheme on the Certificate of Registration (See Appendix K). Note: Where the Construction Products Regulations apply and CE marking is a requirement, this can only be applied following successful evaluation of the factory production control process by a Notified Body. (Notified Bodies are appointed by the relevant authority in a Member State of the European Union and notified to the European Commission. In the UK, the relevant authority for notification under the Constructions Product Regulations (CPR) is the Department for Communities and Local Issue 1 [9001:2015] Page 5 of 48 NHSS 3: 31 July 2016

6 Government (DCLG)). IMPLEMENTATION ISSUE 1 [9001:2015] (i) (ii) (iii) (iv) This document has been produced to supersede the Issue 6 [9001:2008] version (which relates to ISO 9001:2008), however the Issue 6 [9001:2008] version (or a later updated version) will continue to have validity until September 2018 when the 2008 version of ISO 9001 will become obsolete. This issue of the SSD may be implemented immediately from the date of publication on the UKAS website for assessments in accordance with ISO 9001:2015. Implementation requirements described in the Issue 6 [9001:2008] version will continue to apply. Assessments against the Issue 6 [9001:2008] version (or a later updated version) will continue to be valid until September Note: The NHSS document is date specific; however the Organization shall have processes in place to ensure that the latest version is always available. Organizations should be aware that utilization of internet search engines may result in out of date references being identified/called up. INTRODUCTION 1 This Sector Scheme Document (SSD) relates to the quality management system requirements for Organizations that are involved in the stocking and distribution of mechanical fasteners that are to be supplied to a Customer for use in infrastructure assets. It sets out to identify common particular requirements of ISO 9001:2015 for Organizations and Certification Bodies engaged in the sector, and the minimum qualifications that an assessor/auditor requires. The document shall be read in conjunction with ISO 9001: This Sector Scheme is one of the series of National Highway Sector Schemes (NHSSs), which have been developed as bespoke integrated management schemes within an ISO 9001 framework to provide particular requirements for ISO 9001:2015 as applicable to a particular infrastructure related activity/industry within the United Kingdom. 3 Separate Sector Scheme Advisory Committees (SSACs) for each activity within the sector provide advice to UKAS and expert representation is drawn from all sides of industry. Each SSAC interprets ISO 9001 in relation to the requirements of their particular activity and come to a consensus on the minimum levels of workmanship, services, products, testing, and the training and competency of personnel, as appropriate, required to meet specification requirements as well as identified requirements in respect of environmental and health & safety and other aspects. The details are contained in the individual SSDs. Following the publication of a revised ISO 9001, the committees will review their documents to ensure alignment with the revised ISO 9001 to ensure that the SSD does not conflict with the national standard prior to withdrawal of the previous edition of the standard. 4 The individual NHSS technical advisory committees are overseen by the National Highway Sector Scheme Liaison Committee (NHSSLC). This Committee provides a forum for discussion on the effectiveness of the Sector Schemes and co-ordinates developments so that they can be uniformly taken forward by each of the NHSS technical advisory committees. It is also the venue where dialogue with UKAS and the Certification Bodies on the application of the Sector Schemes takes place. Issue 1 [9001:2015] Page 6 of 48 NHSS 3: 31 July 2016

7 5 NHSSs together with ISO 9001 are designed to: Provide an industry benchmark Identify risks and opportunities Ensure that all processes are planned Provide a basis for continuous improvement Focus on quality as an objective Reduce costs for Client and Organization Provide and maintain a properly trained and competent workforce Involve all sides of industry in scheme ownership within a partnership framework Provide the basis for the technical knowledge and experience that Certification Body auditors will use in the sector concerned Promote confidence in quality management systems through provision of a robust transparent system 6 The Sector Scheme shall apply only where specified by the Client in their Contract Documents for the supply of mechanical fasteners. 7 In using this Sector Scheme users shall use best practice such as specifying any other relevant NHSSs as appropriate to the nature of the work being undertaken e.g. NHSS 20 for the execution of steelwork. 8 It should also be noted that NHSSs are mandatory for Highways England contracts, and Suppliers within the supply chain shall demonstrate compliance with the requirements of ISO 9001 and this SSD as part of their continual improvement within their ISO 9001 registration. The use of the Specification for Highway Works as the basic document for procuring highway works by other highway authorities would normally automatically call up compliance with ISO 9001 and this SSD. Other owners of infrastructure, for example Network Rail, may also require their Suppliers to comply with this Sector Scheme, as may other authorities. Separately the document may be called up in specific contracts as necessary. Note: The Sector Scheme has been listed in Appendix A and Series 1800 of the Specification for Highway Works as a means of satisfying a mandatory requirement relating to the supply of mechanical fasteners. 9 In their Model Specification for the Purchase of Structural Bolting Assemblies and Holding Down Bolts the BCSA has made compliance with this Sector Scheme a requirement for suppliers and distributors of mechanical fasteners. 10 The SSD is a live document with the SSACMF meeting at least once a year to develop it as appropriate. Those using the document should always ensure that they have the current version of the document. The SSD may be obtained by visiting the UKAS website ( from where the document can be freely downloaded. Note: Information on relevant Certification Bodies may be obtained from the UKAS website by following the instructions given in Appendix F. This NHSS document is date specific. Organizations should have processes in place to ensure that the latest version is always available. Organizations should be aware that utilisation of internet search engines may result in out of date references being identified/called up. 11 Lantra hosts the register of Organizations on their website ( This is a self-registration list and it is a requirement of this scheme that Organizations register their details on this website and keep them up to date; Certification Bodies will check that the Organization is registered on the website together with all relevant information, including a pdf copy of the current certificate of registration that the Certification Body issues and any other specific documentation to be uploaded specified by this SSD, prior to Issue 1 [9001:2015] Page 7 of 48 NHSS 3: 31 July 2016

8 annual and surveillance visits. 12 Scheme Feedback Any observations, complaints or feedback relating to the operation of this document and the scheme should be addressed using the procedures given in Appendices J1, J2 or J3 as appropriate. Appendix J1 is to be used for observations and general queries concerning the document and general feedback. Appendix J2 relates to the assessment process carried out by Certification Bodies. Appendix J3 relates to policing of the scheme. Completed J1 forms should be sent to the committee chairperson. Completed J2 forms should be sent directly to the relevant Certification Body. Completed J3 forms should be sent to the relevant Highway Authority, Client or HSE as appropriate and indicated on the form. 13 Scheme Contact The Secretary The Sector Scheme Advisory Committee for Mechanical Fasteners Mr G Bowden Highways England Piccadilly Gate Store Street Manchester M1 2WD geoffrey.bowden@highwaysengland.co.uk Tel: +44 (0) Issue 1 [9001:2015] Page 8 of 48 NHSS 3: 31 July 2016

9 Particular Requirements for the Application of ISO 9001: SCOPE 1.1 General This SSD together with ISO 9001:2015 describes the quality management system requirements relating to the stocking and distribution of mechanical fasteners that are to be established by Organizations that stock and distribute mechanical fasteners and supply them to a Customer for use in infrastructure assets. All requirements of this SSD are generic and are intended to be applicable to all Organizations regardless of type, size and product provided. This SSD does not include quality management system requirements relating to the manufacture of mechanical fasteners. The document provides particular requirements for the application of this scheme additional to the requirements of ISO 9001:2015 for this industry and shall be read and implemented in compliance with that standard. The SSD is applicable to the part of the Organization within the scope of the defined QMS carrying out the stocking and distribution of mechanical fasteners. This scheme is not intended to replace other management system requirements or other contractual requirements. The SSD shall be referenced on the Certificate of Registration issued by the Certification Body (see Appendix K). 1.2 Application This SSD is applicable to the supply of mechanical fasteners to be used in infrastructure assets in work on new and existing assets. It is applicable to all mechanical fasteners used in both permanent and temporary connections and to work undertaken in the workshop and on site. This Sector Scheme applies to Organizations that manufactures mechanical fasteners or obtains mechanical fasteners from a Manufacturer or Supplier and who may transport them, store them, rework them, modify them or split them into smaller quantities, and supply them to a Customer for use in infrastructure assets Organizations registered to another NHSS undertaking works that includes activities covered by the scope of this Sector Scheme should refer to Appendix N for guidance on compliance with this Sector Scheme. 2. NORMATIVE REFERENCE The following normative documents contain provisions which constitute provisions of BS EN ISO 9001 Quality Management Systems Requirements: BS EN ISO 9000:2015 Quality Management Systems Fundamentals and vocabulary BS EN ISO 9001:2015 Quality Management Systems Requirements BS EN ISO 9004:2009 Quality Management Systems Managing for the sustained success of an organization. A quality management approach. NHSS 0 Guide to the identification, Development Management and Certification of National Highway Sector Schemes Issue 1 [9001:2015] Page 9 of 48 NHSS 3: 31 July 2016

10 3. TERMS, DEFINITIONS AND ABBREVIATIONS 3.1 For the purpose of this Sector Scheme Document the terms and definitions given in ISO 9000:2015 and NHSS 0 Part 5 shall apply except where listed in the table below. CE marked product A mechanical fastener for which a declaration of performance is required to be drawn up by the Manufacturer in accordance with the Construction Products Regulations (Regulation (EU) No 305/2011 of the European Parliament and of the Council). (See also definition for Manufacturer s Certificate) Certificate of Registration: Client: Contract Specification: Customer: Distributor Importer Infrastructure assets Lot Manufacturer Manufacturer s Certificate Mechanical Fastener; Product A certificate issued by a UKAS accredited Certification Body (or equivalent) certifying that the holder operates a Quality Management System complying with ISO 9001:2015 and this SSD. (See Appendix K) The owner or manager of the infrastructure asset. The specification for the mechanical fastener included in the contract. The body purchasing the mechanical fasteners from the Organization, for use in infrastructure assets. Any natural or legal person in the supply chain, other than the Manufacturer or Importer, who makes a mechanical fastener available on the European Union market. Any natural or legal person established within the European Union, who places a mechanical fastener from a country outside the European Union, on the European Union market. Includes but is not limited to highway and rail bridges, gantries, masts, columns, signal posts, electrification masts, station structures, buildings and toll booths. Does not include traffic signs to BS EN Pt 1, or vehicle restraint systems to BS EN As defined in the standard appropriate for the mechanical fastener under consideration. Any natural or legal person who manufactures or modifies a mechanical fastener or who has a mechanical fastener designed or manufactured, and markets the mechanical fastener under their name or trademark. A Manufacturer may be registered to this SSD for stocking and distribution activities. The declaration of performance issued by the Manufacturer for the mechanical fastener, which for CE marked product shall be in the language or languages required by the Member State of the European Union where the mechanical fastener is to be made available. The component and or assembly used to mechanically Issue 1 [9001:2015] Page 10 of 48 NHSS 3: 31 July 2016

11 connect two or more elements. An assembly shall be as defined in the appropriate standard. Organization: shall : splitting stockist distributor Supplier, Provider Supply The Manufacturer of mechanical fasteners or the stockist distributor of mechanical fasteners, who shall be assessed against this SSD for stocking and distribution activities, and who supplies mechanical fasteners to the Customer. Used to indicate a requirement strictly to be followed in order to conform to the standard and from which no deviation is permitted. (See ISO/IEC Directives Part 3:1997, Annex E) (reference guidance on terminology used in ISO 9001 and ISO 9004.) The separation of mechanical fasteners belonging to the same lot into smaller quantities. An Importer or Distributor of mechanical fasteners. A stockist distributor may be an Organization or Supplier within the supply chain of mechanical fasteners. (See Supply Chain Diagram Below) A stockist distributor, who may be registered to this SSD, who supplies mechanical fasteners to the Organization. (See Supply Chain Diagram Below) The making available of the necessary information, services, products and/or materials to meet the requirements specified in the contract. Issue 1 [9001:2015] Page 11 of 48 NHSS 3: 31 July 2016

12 APPLICATION OF DEFINITIONS TO THE MECHANICAL FASTENER SUPPLY CHAIN. NHSS 3 Definitions (See Section 3) Manufacturer Supplier Organization Customer (May be NHSS 3 Registered) (May be NHSS 3 Registered) (Must be NHSS 3 Registered) Manufacturer (stocking and distribution activities) Steelwork Contractor Manufacturer Stockist Distributor Steelwork Contractor Manufacturer Stockist Distributor Stockist Distributor Steelwork Contractor 3.2 For the purpose of this Sector Scheme Document the following abbreviations shall apply: NHSS QMS SSAC National Highway Sector Scheme Quality Management System Sector Scheme Advisory Committee SSACMF Sector Scheme Advisory Committee for Mechanical Fasteners. SSD UKAS Sector Scheme Document The United Kingdom Accreditation Body or any recognised European National Accreditation Body or any equivalent International Accreditation Forum (IAF) Multi-Lateral Agreement (MLA) signatory Issue 1 [9001:2015] Page 12 of 48 NHSS 3: 31 July 2016

13 4 to 10 QUALITY MANAGEMENT SYSTEM REQUIREMENTS Particular Requirements ISO 9001:2015 Introduction This document needs to be read in conjunction with the requirements of ISO 9001:2015 Clause/Paragraph numbers in this section reference appropriate paragraphs of ISO 9001:2015. The requirements of ISO 9001:2015 are deemed to apply unless specific additions are required. Where no specific particular requirement is recorded under an ISO 9001 clause heading this means that it is not considered necessary to provide a particular requirement for that clause. The particular requirements given below are to assist in the clarification of the ISO 9001 text for the relevant activity, no inference should be made that ISO 9001 requirements are diluted or deleted because of this particular requirement. 4 Context of the Organization 4.1 Understanding the Organization and its context No specific particular requirement. 4.2 Understanding the needs and expectations of interested parties Interested parties shall include the Customer and Client. 4.3 Determining the scope of the quality management system The scope of the quality management system shall cover the stocking and distribution of mechanical fastener services that the Organization is competent to supply and for which they are seeking registration. 4.4 Quality management system and its processes The Organization shall operate a quality management system to ISO 9001:2015 and this SSD (i) The Organization shall have a process in place to record/update their registration to this sector scheme on the Schedule of Suppliers website immediately following confirmation of their certification/re-certification to the sector scheme from the certification body and check its suitability annually. (See Appendix O for information) (ii) The Organization shall notify the LANTRA Awards NHSS Schedule of Suppliers if Certification is suspended or withdrawn. Issue 1 [9001:2015] Page 13 of 48 NHSS 3: 31 July 2016

14 5 Leadership 5.1 Leadership and commitment General The Organization s policy document shall include Top Management support for this NHSS Customer focus 5.2 Policy No specific particular requirement Establishing the quality policy The Organization s quality policy statement shall include a statement of commitment to applicable National Highway Sector Schemes Communicating the quality policy No specific particular requirement. 5.3 Organization roles, responsibilities and authorities No specific particular requirement. 6 Planning 6.1 Actions to address risks and opportunities The Organisation shall take into account the risks and opportunities relating to this NHSS No specific particular requirement. 6.2 Quality objectives and planning to achieve them (i) The quality objectives shall include a commitment to meet Customer and Client requirements with respect to the stocking and distribution of mechanical fasteners. (ii) The quality objectives shall include maximising opportunities for the re-use and recovery of wastes No specific particular requirement. 6.3 Planning of changes No specific particular requirement. 7 Support 7.1 Resources Issue 1 [9001:2015] Page 14 of 48 NHSS 3: 31 July 2016

15 7.1.1 General People The Organization shall be able to demonstrate that it is able to meet its Customer order commitments. No specific particular requirement Infrastructure The Organization shall determine, provide and maintain the infrastructure to confirm and maintain conformity of mechanical fasteners Environment for the operation of processes The Organization shall consider all factors that may affect maintaining mechanical fastener conformity including but not limited to temperature, humidity, lighting and cleanliness Monitoring and measuring resources General The Organization shall establish and maintain a record of the monitoring and measuring devices used in the verification, preservation and supply of mechanical fasteners. (See Appendix E for guidance.) Measurement traceability The Organization shall implement and maintain processes for the calibration of monitoring and measuring devices. Where no standard exists, monitoring and measuring devices shall be calibrated in accordance with the manufacturer s instructions or the Organization s own procedures Organizational knowledge No specific particular requirement. 7.2 Competence No specific particular requirement. 7.3 Awareness No specific particular requirement. 7.4 Communication The Organization shall ensure that personnel have access to quality management system documentation, and that the standard operating processes appropriate to their responsibilities are communicated to all relevant employees. 7.5 Documented information Issue 1 [9001:2015] Page 15 of 48 NHSS 3: 31 July 2016

16 7.5.1 General The Organization shall have in place auditable processes to identify publication of relevant new standards and documents, and implementation requirements (See Appendix B, Note 2) Creating and updating No specific particular requirement Control of documented Information No specific particular requirement (i) The Organization shall have processes in place to ensure that the latest versions of relevant standards and documents are always available (See Appendix B). (ii) The Organization shall typically keep the following records: a) Customer order including product requirements including any variations, and product delivery records. b) Manufacturer s Certificates and Inspection Documents. c) Manufacturer s technical documentation, product information, instructions and safety information. d) Verification records including records of inspection and testing of mechanical fasteners carried out by the Organization (See 8.4.2). e) Calibration and test records of any test equipment used. f) Storage control and stock rotation records for time dependent product. g) Records to enable mechanical fastener traceability (lot traceability) including following splitting. h) Product recalls. i) Non-conformance, corrective action and preventive action records. j) Complaints and feedback. k) Manufacturers performance reviews (See 8.4.1) (iii) Product related records shall be kept for a minimum of ten years after the construction product has been placed on the market. (iv) Customer specific records shall be kept for a minimum of ten years unless otherwise required to be retained for a longer period in the Customer order. Records shall be made available to the Customer and/or Client as requested in accordance with contract requirements. (v) Where records are stored in an electronic form the integrity of the system and the backup procedures shall be appropriately validated. These records shall be traceable to the original documentation. 8 Operation 8.1 Operational planning and control No specific particular requirement. 8.2 Requirements for products and services Issue 1 [9001:2015] Page 16 of 48 NHSS 3: 31 July 2016

17 8.2.1 Customer communication The Organization shall ensure that documents required by the Customer order/specification to accompany the mechanical fastener are provided when requested by the means specified by the Customer, and are protected against loss and deterioration. The documents to accompany the mechanical fastener shall include any Manufacturer product instructions and safety information in a language that can be easily understood by users Determining the requirements for products and services No specific particular requirement Review of the requirements for products and services (i) The Organization shall review in a timely manner the Customer order to verify that product requirements are defined and that they are able to meet those product requirements. (ii) From the outset and during the progress of fulfilling the Customer order the Organization shall review: a) The risks associated with meeting the Customer order including delivery timescales; and b) Opportunities for control of risks and performance improvement relating to the Customer order. (iii) Where omissions, irregularities or inconsistencies with the Customer order or other Customer related issues are encountered these shall be brought to the attention of the Customer for resolution No specific particular requirement Changes to requirements for products and services No specific particular requirement. 8.3 Design and development of products and services Not applicable to this Sector Scheme. 8.4 Control of externally provided processes, products and services General (i) (ii) Organizations shall: a) Maintain a register of approved Manufacturers and Suppliers of mechanical fasteners that includes the scope of approval. The scope of approval shall include maintaining the Manufacturer s identification and lot traceability. b) Periodically review Manufacturers and Suppliers performance in meeting specified purchase requirements; records of these reviews shall be used as a basis for establishing the frequency of review and level of controls to be implemented. c) Define the necessary actions to take when dealing with Manufacturers and Suppliers that do not meet specified purchase requirements. d) Prevent the purchase of counterfeit/nonconforming mechanical fasteners. The Organization shall be responsible for the quality of all products purchased from Issue 1 [9001:2015] Page 17 of 48 NHSS 3: 31 July 2016

18 Manufacturers and Suppliers, including customer-designated sources Type and extent of control Organizations shall implement and maintain processes that are suitable for ensuring that purchased mechanical fasteners meet specified purchase requirements. Such verification processes shall include but are not necessarily limited to: a) Obtaining objective evidence of the authenticity and quality of the mechanical fasteners such as Manufacturer s Certificates and/or test reports from Manufacturers and/or Suppliers. b) Review of the mechanical fastener documentation to confirm authenticity, relevance, accuracy and completeness. c) Inspection and sample testing of the mechanical fasteners upon receipt or evidence of inspection and sample testing of the mechanical fasteners undertaken by an independent testing laboratory accredited in accordance with BS EN ISO/IEC 17025:2005 (See Note below), or by a Manufacturer or Supplier registered to this Sector Scheme. The inspection and sample testing shall include verification of dimensional characteristics and testing of the mechanical characteristics of the mechanical fasteners. (See 8.6) Note: The accreditation of the testing laboratory shall be by UKAS or equivalent European accreditation organisation which is party to a multi-lateral agreement (MLA) with UKAS or any other equivalent International Accreditation Forum MLA signatory with a scope that includes BS EN ISO/IEC 17025: Information for external providers Purchasing information for mechanical fasteners shall include: a) The mechanical fastener description or other positive identification. b) The relevant standards, specifications and Inspection Document for the mechanical fasteners. c) For CE marked product, requirements for notification of the Manufacturer s and where applicable the Importer s name, registered trade name or registered trade mark, and address, which shall be a single point of contact in the case of the Manufacturer. d) Requirements for Manufacturer and Supplier notification to the Organization of any non-conforming product which shall include notification of any nonconforming product that could present a risk (e.g. affects reliability or safety). e) Requirements for a Manufacturer s Certificate (including appropriate marking where relevant) and/or test reports, together with any related Manufacturer technical documentation (See Note below), product information, instructions and safety information in a language that can be easily understood by users. f) Requirements for notification of any specific Manufacturer s requirements for preservation of mechanical fasteners in the condition as supplied by the Manufacturer. Note: For CE marked product, this shall describe all the relevant elements related to the required system of assessment and verification of constancy of performance. 8.5 Production and service provision Control of production and service provision The Organization shall ensure that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out Identification and traceability Issue 1 [9001:2015] Page 18 of 48 NHSS 3: 31 July 2016

19 (i) (ii) (iii) The Organization shall implement and maintain documented processes to ensure that retained documents and records can be clearly identified and traced. The Organization shall implement and maintain documented processes to ensure the identification and traceability of mechanical fasteners by suitable means from receipt, during transportation, splitting, storage, packaging, and until delivery. The Organizations processes shall include: a) Maintaining the Manufacturer s identification and lot traceability. b) The ability to identify and trace mechanical fasteners from the same lot. c) For CE marked product, the ability to identify the Manufacturer s and where applicable the Importer s name, registered trade name or registered trade mark, and address Property belonging to customers or external providers No specific particular requirement Preservation The Organization shall implement and maintain documented processes for the appropriate transportation, handling, storage, splitting and packaging to ensure the preservation of mechanical fasteners in their condition as supplied by the Manufacturer. The processes shall make provisions for: a) Any Manufacturer s recommendations/requirements. b) Storage control and stock rotation Post-delivery activities No specific particular requirement Control of changes No specific particular requirement. 8.6 Release of products and services (i) (ii) (iii) (iv) Inspection and sample testing shall be in accordance with BS EN ISO 3269:2001 for dimensional characteristics, and BS EN ISO 3269:2001 and Appendix P for mechanical characteristics. Mechanical property requirements for mechanical fastener acceptance shall be documented and include: a) criteria for acceptance and/or rejection, b) a record of the measurement results, and c) type of measurement instruments required and any specific instructions associated with their use. Test records shall show actual test results data. When required by the Customer, a market surveillance authority or competent national authority, the Organization shall provide evidence of the product s conformity to its technical specifications. This may include conformance documents, such as the original Manufacturer s Certificate and/or the evidence obtained under in verifying mechanical fasteners. Issue 1 [9001:2015] Page 19 of 48 NHSS 3: 31 July 2016

20 (v) (vi) When splitting product, records shall be kept recording amount delivered, purchase order number and Customer's name. When agreed with the Customer, the Organization may provide a Manufacturer s Certificate created by the Organization that references the original Manufacturer's Certificate that are retained and traceable by the Organization. 8.7 Control of nonconforming outputs (i) Non-conforming product includes any nonconforming product returned from a Customer. (ii) The Organization shall implement and maintain documented processes to ensure that mechanical fasteners that they consider or have reason to believe are non-conforming product are not placed or made available on the market and that where the product presents a risk (e.g. affects reliability or safety), the Manufacturer or the Importer and market surveillance authorities are informed. (iii) The Organization shall implement and maintain documented processes to deal with mechanical fasteners that they have placed or made available on the market and that they subsequently consider or have reason to believe are non-conforming product. The processes shall include as appropriate investigating the non-conformance and taking the necessary action to bring the mechanical fasteners into conformity, withdrawal, recall and disposal of non-conforming product. (iv) The Organization shall ensure, with the Manufacturer or the Importer, that similar mechanical fasteners are not similarly affected and shall where necessary inform the Customer and other customers of any non-conformities affecting mechanical fasteners already delivered. (v) In addition to any contract reporting requirements, the Organization s processes shall provide for timely reporting of delivered non-conforming product that may present a risk (e.g. affects reliability or safety). Notification shall include a clear description of the nonconformity, which includes as necessary parts affected, Customer and/or Organization part numbers, quantity, date(s) delivered, and details of any corrective measures taken. Note: Parties requiring notification of non-conforming product may include Manufacturers, Importers, market surveillance authorities, relevant competent national authorities, suppliers, internal organisations, customers and stockist distributors. (vi) Disposal of non-conforming product shall be limited to: - scrap; - rejection for return to the Supplier; - rejection for revalidation by the Manufacturer; - submittal to Customer for USE AS IS disposal. - rework/repair and revalidation by the Organization Product disposed of as scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable No specific particular requirement. 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation Issue 1 [9001:2015] Page 20 of 48 NHSS 3: 31 July 2016

21 9.1.1 General No specific particular requirement Customer satisfaction No specific particular requirement Analysis and evaluation (i) (ii) Statistical techniques may be applied in inspecting and testing mechanical fasteners so long as they are statistically valid and appropriate for use. In the event of process nonconformity, the Organization shall: a) Take appropriate action to correct the nonconforming process, b) Evaluate whether the process nonconformity has resulted in mechanical fastener nonconformity, c) Identify and control any nonconforming mechanical fasteners in accordance with Internal audit No specific particular requirement (i) Internal audits shall be carried out at sufficient frequency and by a suitable technically competent person/s to ensure a robust assessment of the compliance of the product. (ii) Internal audits of the quality management system against this SSD shall include office-based audits of the processes associated with stocking and distribution, at no more than twelve monthly intervals. 9.3 Management review General The Organization shall review the quality management system at least once every twelve months to ensure its continuing suitability and effectiveness to conform to this NHSS Management review inputs No specific particular requirement Management review outputs The output and actions from the management review shall be considered by Top Management at regular intervals throughout the year. 10 Improvement 10.1 General No specific particular requirement Nonconformity and corrective action Issue 1 [9001:2015] Page 21 of 48 NHSS 3: 31 July 2016

22 No specific particular requirement No specific particular requirement Continual improvement No specific particular requirement. Issue 1 [9001:2015] Page 22 of 48 NHSS 3: 31 July 2016

23 APPENDIX A: REQUIREMENTS FOR QUALITY PLANS Not used. Issue 1 [9001:2015] Page 23 of 48 NHSS 3: 31 July 2016

24 APPENDIX B: NOTE:- REFERENCE AND ASSOCIATED DOCUMENTS (BIBLIOGRAPHY) 1. The listing is not comprehensive; other documents may be required to fulfil the requirements of the contract. Organizations shall ensure that they have a working knowledge of and access to all the documents including amendments unless stated otherwise in the specification 2. Organizations shall ensure they are working to current reference or associated documents appropriate to work in their sector. (See 7.5.1) 3. The list of standards and documents below are date specific, however, the Organization shall have processes in place to ensure that the latest version is always available. Organizations should be aware that utilisation of internet search engines may result in out of date references being identified/called up. REFERENCE DOCUMENTS Reference should be made to the Customer Order for specific reference documents. See Section 2 for Normative References. General Reference Documents BS EN ISO 3269:2001 Fasteners Acceptance Inspection BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories This list of standards and documents include those that are date specific, however, the Organization shall have processes in place to ensure that the latest versions are always available. (See 7.5.2) Issue 1 [9001:2015] Page 24 of 48 NHSS 3: 31 July 2016

25 APPENDIX C: TRAINING AND ASSESSMENT OF COMPETENCE Not used. Issue 1 [9001:2015] Page 25 of 48 NHSS 3: 31 July 2016

26 APPENDIX D: ATTAINMENTS EXAMPLE REGISTER OF PERSONNEL Not used. Issue 1 [9001:2015] Page 26 of 48 NHSS 3: 31 July 2016

27 APPENDIX E: GUIDANCE FOR THE CONTROL OF MONITORING AND MEASURING EQUIPMENT Example Record of Monitoring and Measuring Devices Equipment & Unique Reference Number Equipment/ Test Specification Calibration Control Calibration Frequency Date of Calibration Date Next Calibration Due. Calibration Certificate Ref. Note 1. In house calibrations to be in accordance with procedure(s) described in the equipment s operating manual. Separate records are to be kept on method(s) used and results of calibration. 2. All Calibrations (other than in house ) shall be certified by accredited/registered Inspection Bodies providing certification of calibration traceable to national standards wherever possible / practical. 3. Records of all equipment in use, their calibration status and calibration or verification checks undertaken shall be implemented and maintained. Issue 1 [9001:2015] Page 27 of 48 NHSS 3: 31 July 2016

28 APPENDIX F: CERTIFICATION BODIES ACCREDITED FOR THIS SECTOR SCHEME Information on certification bodies accredited against this sector scheme can be found on the UKAS website To identify the certification bodies on the website: From the UKAS home page Left click in the blue FIND box in top right hand corner of the page; this will open the Search Accredited Organisations page In the Enter Search Term box type in sector scheme No X ( including the inverted commas) (see Notes 1 & 2 below) Left click Search Left click on the Certification Body results This then lists the certification bodies that are accredited to NHSS X and their details can be found by clicking on the appropriate links. Note 1: X represents the scheme number Note 2: This process will not identify certification bodies that do not have sector scheme No X in their scope, but which may have other sector scheme descriptions such as NHSS X or sector scheme X. To complete the full list of accredited CBs it will be necessary to repeat the process (at least twice) by typing in other sector scheme descriptions such as nhss X or sector scheme X as appropriate at bullet point 3. This should then list the certification bodies who are accredited to the scheme and their details can be found by clicking on the appropriate links. Note 3: Advice on the current accreditation status of certification bodies to assess against this document should be sought from UKAS (Tel ). Note 4: The following Certification Bodies are accredited by UKAS to this Sector Scheme at the time of preparing this issue of the SSD. Lloyd s Register Quality Assurance Limited SGS United Kingdom Ltd Steel Construction Certification Scheme Limited Issue 1 [9001:2015] Page 28 of 48 NHSS 3: 31 July 2016

29 APPENDIX G: THE ROLE OF CERTIFICATION BODIES AND AUDITOR QUALIFICATIONS 1. Role of certification bodies 1.1. The independent assessment of conformity of organizations to the requirements of ISO 9001:2015 and this SSD rely upon the assessment expertise, competence and capability of accredited certification bodies The certification body role is to ensure, through assessment, that organizations have management systems in place which address the enhanced ISO 9001:2015 requirements detailed in this SSD Certification bodies shall ensure they are all represented by at least one nominated individual lead certification body (or deputy) who will represent all certification bodies at meetings of this Sector Scheme Advisory Committee. This does not preclude other certification bodies from attending, as appropriate Certification bodies shall be represented at the National Highway Sector Scheme Liaison Committee. 2. Certification body accreditation 2.1. To ensure consistency and to demonstrate independent capability certification bodies are required to be accredited against the requirements of ISO by UKAS for assessment and registration of ISO 9001:2015 quality management systems in accordance with the particular requirements of this NHSS or other equivalent international management scheme. 3. Assessor and assessment team competence The certification body must be able to demonstrate to UKAS that it possesses and can maintain the necessary assessor experience and technical understanding of stocking and distribution activities for mechanical fasteners covered in the scope of this Sector Scheme. These assessment areas shall include, but not be limited to the following: i) knowledge, understanding and application of this SSD (See Appendix G1). ii) knowledge of the mechanical fastener supply chain, including the methods and techniques sufficient to understand the processes employed and the controls necessary to ensure delivery of conforming product. (Conveyance of this knowledge to auditing teams will be determined by the Certification Body and will be audited by UKAS). iii) ability to demonstrate that they have ongoing suitable health and safety training which shall include appreciation of the risks involved in the stocking and distribution of mechanical fasteners. iv) preferably have knowledge of mechanical fasteners, their properties and related standards, and an awareness of the importance of inspection and testing of the product Guidance to Certification Bodies on assessor competence related to this Sector Scheme is given in the certification body guidance document National Highway Sector Scheme Accreditation, Registration and Assessment Guidance for Certification Bodies NHSS 0 Part 4. Issue 1 [9001:2015] Page 29 of 48 NHSS 3: 31 July 2016

30 3.3. The certification body is responsible for ensuring that the assessment teams possess demonstrable expertise in the assessment areas detailed above as they relate to the scope of client activities under assessment Minimum assessor qualifications and competence for assessment of this NHSS, which may reside in a single individual, or in an assessment team are as follows: i) International Register of Certificated Auditors (IRCA) Registered ISO 9001:2015 Lead Auditor qualification or certification body equivalent and demonstrable expertise in leading assessment teams. ii) iii) iv) ISO 9001:2015 assessment experience obtained from assessments of stocking and distribution activities in two different organizations. Technical assessment competence in mechanical fastener stocking and distribution activities. knowledge, understanding and application of this SSD v) knowledge of the mechanical fastener supply chain sufficient to understand the processes employed and the controls necessary to ensure delivery of conforming product. (Conveyance of this knowledge to auditing teams will be determined by the Certification Body and will be audited by UKAS). vi) vii) ability to demonstrate that they have ongoing suitable health and safety training which shall include appreciation of the risks involved in the stocking and distribution of mechanical fasteners. preferably have knowledge of mechanical fasteners, their properties and related standards, and an awareness of the importance of inspection and testing of the product. 4. Conduct of Assessments Certification Bodies shall ensure that an adequate proportion (50%) of the initial and continuing assessment duration is devoted to assessing operational activities at sites and locations where stocking and distribution activities covered by the scope of this Sector Scheme are being undertaken from Certification Bodies shall make every endeavour to ensure that during a three year certification cycle there is evidence of assessment of all activities covered by the Organization s scope of registration. Certification Bodies shall undertake surveillance visits at intervals of not greater than one year. 5. Format and Content of Registration Certificates Certificates of registration issued by Certification Bodies, which include within the scope of registration reference to compliance with this Sector Scheme, shall be in a format and contain the content detailed in Appendix K of this SSD The National Highway Sector Scheme Logo shall be included in any Certificate of Registration which has this Sector Scheme detailed in the Scope of Registration. The logo shall only be used and applied in the manner detailed in any conditions of use which may be published in NHSS National Highway Sector Schemes Schedule of Suppliers. Issue 1 [9001:2015] Page 30 of 48 NHSS 3: 31 July 2016